title: Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response.
abstract: BACKGROUND
  Few randomized controlled trials (RCTs) have been conducted to establish evidence-based management protocols for provoked vestibulodynia (PVD), a chronic vulvar pain condition affecting approximately 14 million women in the U.S. We describe the rationale and design of an NIH funded multicenter clinical trial utilizing an extended release formulation of gabapentin (G-ER), an intervention that preliminary data suggest may be efficacious for this condition.
  
  
  OBJECTIVE
  1) to determine if pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with G-ER compared to when treated with placebo and 2) to determine if G-ER reduces vulvar mechanical hyperalgesia, vaginal muscle pain to palpation, the number and intensity of somatic tenderpoints, spontaneous and provoked pain to intradermal capsaicin with an accompanying increase in cardiac beat-to-beat variability and to identify mechanistically-based PVD subtypes. Additional outcomes include subject reported intercourse pain and summative 24-hour pain.
  
  
  METHODS
  This 16-week, randomized, double-blind, placebo-controlled, crossover study will enroll 120 women 18 years and older who report tenderness localized to the vulvar vestibule, pain with tampon insertion, and, when sexually active, insertional dyspareunia. Electronically entered daily diaries will be used to determine if pain is lower in PVD subjects when treated with G-ER (up to 3000 mg/d) compared to when treated with placebo. Psychophysiological measures will be obtained at baseline and after 2 weeks at the maximum tolerated dose.
  
  
  CONCLUSIONS
  We will conduct the first multicenter RCT to confirm efficacy of an agent that is currently used in clinical practice for treating PVD.
authors.affiliation: Department of Clinical Pharmacy, University of Tennessee Health Science Center, Memphis, TN 38163, USA. csbrown@uthsc.edu
authors.forename: Candace S
authors.initials: CS
authors.lastname: Brown
authors.forename: David C
authors.initials: DC
authors.lastname: Foster
authors.forename: Jim Y
authors.initials: JY
authors.lastname: Wan
authors.forename: Leslie A
authors.initials: LA
authors.lastname: Rawlinson
authors.forename: Gloria A
authors.initials: GA
authors.lastname: Bachmann
mesh_terms: D000588:Amines / Q000008:administration & dosage / Q000627:therapeutic use*; D000700:Analgesics / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003509:Cyclohexanecarboxylic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy / Q000523:psychology; D005260:Female; D000077206:Gabapentin; D006801:Humans; D010147:Pain Measurement / Q000379:methods; D012107:Research Design; D056650:Vulvodynia / Q000188:drug therapy* / Q000523:psychology; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000588:Amines; D000700:Analgesics; D003509:Cyclohexanecarboxylic Acids; D003692:Delayed-Action Preparations; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin
keywords: Biological correlates; Gabapentin; Multicenter clinical trial; Provoked vestibulodynia; Vulvodynia